Effectiveness and Safety of Intradetrusor OnabotulinumtoxinA Injection for Neurogenic Detrusor Overactivity and Overactive Bladder Patients in Taiwan—A Phase IV Prospective, Interventional, Multiple-Center Study (Restore Study)
We conducted a phase IV, pre/post multi-center study to evaluate the efficacy and safety of intradetrusor onabotulinumtoxinA injection in patients with neurogenic detrusor overactivity (NDO, <i>n</i> = 119) or overactive bladder (OAB, <i>n</i> = 215). Patients received either...
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MDPI AG
2021-12-01
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| Series: | Toxins |
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| Online Access: | https://www.mdpi.com/2072-6651/13/12/911 |
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| author | Chung-Cheng Wang Eric Chieh-Lung Chou Yao-Chi Chuang Chih-Chieh Lin Yu-Chao Hsu Chun-Hou Liao Hann-Chorng Kuo |
| author_facet | Chung-Cheng Wang Eric Chieh-Lung Chou Yao-Chi Chuang Chih-Chieh Lin Yu-Chao Hsu Chun-Hou Liao Hann-Chorng Kuo |
| author_sort | Chung-Cheng Wang |
| collection | DOAJ |
| description | We conducted a phase IV, pre/post multi-center study to evaluate the efficacy and safety of intradetrusor onabotulinumtoxinA injection in patients with neurogenic detrusor overactivity (NDO, <i>n</i> = 119) or overactive bladder (OAB, <i>n</i> = 215). Patients received either 200U (i.e., NDO) and 100U (i.e., OAB) of onabotulinumtoxinA injection into the bladder, respectively. The primary endpoint for all patients was the change in the PPBC questionnaire score at week 4 and week 12 post-treatment compared with baseline. The secondary endpoints were the changes in subjective measures (i.e., questionnaires: NBSS for patients with NDO and OABSS for those with OAB) at week 4 and week 12 post-treatment compared with baseline. Adverse events included symptomatic UTI, de novo AUR, gross hematuria and PVR > 350mL were recorded. The results showed that compared with baseline, PPBC (3.4 versus 2.4 and 2.1, <i>p</i> < 0.001) and NBSS (35.4 versus 20.4 and 18.1, <i>p</i> < 0.001) were significantly improved at 4 weeks and 12 weeks in NDO patients. In addition, compared with baseline, PPBC (3.5 versus 2.3 and 2.0, <i>p</i> < 0.001) and OABSS (9.1 versus 6.2 and 5.7, <i>p</i> < 0.001) were significantly improved at 4 weeks and 12 weeks in OAB patients. Eight (6.7%) had symptomatic UTI and 5 (4.2%) had de novo AUR in NDO patients. Twenty (9.3%) had symptomatic UTI but no de novo AUR in OAB patients. In conclusion, we found that intradetrusor onabotulinumtoxinA injections were safe and improved subjective measures related to NDO or OAB in our cohort. |
| first_indexed | 2024-03-10T03:58:19Z |
| format | Article |
| id | doaj.art-b311ed8ab3d3457888e3f4d0db932dc9 |
| institution | Directory Open Access Journal |
| issn | 2072-6651 |
| language | English |
| last_indexed | 2024-03-10T03:58:19Z |
| publishDate | 2021-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Toxins |
| spelling | doaj.art-b311ed8ab3d3457888e3f4d0db932dc92023-11-23T10:51:19ZengMDPI AGToxins2072-66512021-12-01131291110.3390/toxins13120911Effectiveness and Safety of Intradetrusor OnabotulinumtoxinA Injection for Neurogenic Detrusor Overactivity and Overactive Bladder Patients in Taiwan—A Phase IV Prospective, Interventional, Multiple-Center Study (Restore Study)Chung-Cheng Wang0Eric Chieh-Lung Chou1Yao-Chi Chuang2Chih-Chieh Lin3Yu-Chao Hsu4Chun-Hou Liao5Hann-Chorng Kuo6Department of Urology, En Chu Kong Hospital, New Taipei City 237414, TaiwanDepartment of Urology, China Medical University Hospital, School of Medicine, China Medical University, Taichung 406040, TaiwanDepartment of Urology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 833401, TaiwanShu-Tien Urological Research Center, Department of Urology, Taipei Veterans General Hospital, School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei 112304, TaiwanDepartment of Urology, Linko Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyung 333323, TaiwanDepartment of Urology, Cardinal Tien Hospital, School of Medicine, Fu-Jen Catholic University, New Taipei City 242062, TaiwanDepartment of Urology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Buddhist Tzu Chi University, Hualiang 970374, TaiwanWe conducted a phase IV, pre/post multi-center study to evaluate the efficacy and safety of intradetrusor onabotulinumtoxinA injection in patients with neurogenic detrusor overactivity (NDO, <i>n</i> = 119) or overactive bladder (OAB, <i>n</i> = 215). Patients received either 200U (i.e., NDO) and 100U (i.e., OAB) of onabotulinumtoxinA injection into the bladder, respectively. The primary endpoint for all patients was the change in the PPBC questionnaire score at week 4 and week 12 post-treatment compared with baseline. The secondary endpoints were the changes in subjective measures (i.e., questionnaires: NBSS for patients with NDO and OABSS for those with OAB) at week 4 and week 12 post-treatment compared with baseline. Adverse events included symptomatic UTI, de novo AUR, gross hematuria and PVR > 350mL were recorded. The results showed that compared with baseline, PPBC (3.4 versus 2.4 and 2.1, <i>p</i> < 0.001) and NBSS (35.4 versus 20.4 and 18.1, <i>p</i> < 0.001) were significantly improved at 4 weeks and 12 weeks in NDO patients. In addition, compared with baseline, PPBC (3.5 versus 2.3 and 2.0, <i>p</i> < 0.001) and OABSS (9.1 versus 6.2 and 5.7, <i>p</i> < 0.001) were significantly improved at 4 weeks and 12 weeks in OAB patients. Eight (6.7%) had symptomatic UTI and 5 (4.2%) had de novo AUR in NDO patients. Twenty (9.3%) had symptomatic UTI but no de novo AUR in OAB patients. In conclusion, we found that intradetrusor onabotulinumtoxinA injections were safe and improved subjective measures related to NDO or OAB in our cohort.https://www.mdpi.com/2072-6651/13/12/911overactive bladderonabotulinum toxin Aneurogenic detrusor overactivity |
| spellingShingle | Chung-Cheng Wang Eric Chieh-Lung Chou Yao-Chi Chuang Chih-Chieh Lin Yu-Chao Hsu Chun-Hou Liao Hann-Chorng Kuo Effectiveness and Safety of Intradetrusor OnabotulinumtoxinA Injection for Neurogenic Detrusor Overactivity and Overactive Bladder Patients in Taiwan—A Phase IV Prospective, Interventional, Multiple-Center Study (Restore Study) Toxins overactive bladder onabotulinum toxin A neurogenic detrusor overactivity |
| title | Effectiveness and Safety of Intradetrusor OnabotulinumtoxinA Injection for Neurogenic Detrusor Overactivity and Overactive Bladder Patients in Taiwan—A Phase IV Prospective, Interventional, Multiple-Center Study (Restore Study) |
| title_full | Effectiveness and Safety of Intradetrusor OnabotulinumtoxinA Injection for Neurogenic Detrusor Overactivity and Overactive Bladder Patients in Taiwan—A Phase IV Prospective, Interventional, Multiple-Center Study (Restore Study) |
| title_fullStr | Effectiveness and Safety of Intradetrusor OnabotulinumtoxinA Injection for Neurogenic Detrusor Overactivity and Overactive Bladder Patients in Taiwan—A Phase IV Prospective, Interventional, Multiple-Center Study (Restore Study) |
| title_full_unstemmed | Effectiveness and Safety of Intradetrusor OnabotulinumtoxinA Injection for Neurogenic Detrusor Overactivity and Overactive Bladder Patients in Taiwan—A Phase IV Prospective, Interventional, Multiple-Center Study (Restore Study) |
| title_short | Effectiveness and Safety of Intradetrusor OnabotulinumtoxinA Injection for Neurogenic Detrusor Overactivity and Overactive Bladder Patients in Taiwan—A Phase IV Prospective, Interventional, Multiple-Center Study (Restore Study) |
| title_sort | effectiveness and safety of intradetrusor onabotulinumtoxina injection for neurogenic detrusor overactivity and overactive bladder patients in taiwan a phase iv prospective interventional multiple center study restore study |
| topic | overactive bladder onabotulinum toxin A neurogenic detrusor overactivity |
| url | https://www.mdpi.com/2072-6651/13/12/911 |
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